The Recall Desk
HighFDA (Devices)·Z-1309-2022·Announced 2022-07-06

GCX Channel Mounting Accessory Screws May Loosen or Pull Out

Skytron recalls its GCX Channel Mounting Accessory (model H8-300-40-A) because mounting screws may loosen or pull out when used as a monitor mount on surgical booms. Affected units were distributed worldwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II medical device recall involves mounting screws that may loosen or pull out from a surgical boom mount. No deaths, hospitalizations, or reported injuries are documented. Per the severity rubric, risk-of-harm products where injury has not yet been reported are classified as High (score 3).

Plain-English summary

Skytron, Div. The KMW Group, Inc is recalling the GCX Channel Mounting Accessory, model H8-300-40-A, a mounting bracket used with surgical equipment booms to attach monitors.

Under certain circumstances, the mounting screws securing the accessory may loosen or pull out from the attachment point on the Ergon 3 boom when the accessory is used with the VST clamp as a monitor mount.

A total of 731 units are affected. The accessory was distributed worldwide to customers in the United States, Canada, and Japan.

Consumers who believe they have affected equipment should contact Skytron for information about the recall and any available remedy.

The recalled product

Product
Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A
Manufacturer
Skytron, Div. The KMW Group, Inc
Category
Medical Device — Surgical Equipment
Hazard
Affected units
731

Distribution

Distributed nationwide across the United States.

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